This phase II trial is studying how well giving cediranib maleate together with combination chemotherapy works in treating patients with advanced biliary cancers. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cediranib maleate together with combination chemotherapy may kill more tumor cells.

Estimation of the response rate of patients with advanced biliary cancers treated with cediranib maleate and modified FOLFOX6 evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Estimated based on the number of responses using a binomial distribution and its confidence intervals will be estimated using Wilson's method. The 95% confidence intervals should be provided.

Secondary Outcome Measures:

Tabulation of the toxicity profile of the combination therapy [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]

Number of patients that experience each >/= grade 3 treatment related toxicities

Estimation of the time to disease progression evaluated using the RECIST v1.1 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Kaplan-Meier method will be used.

Estimation of overall survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

I. To determine overall assessment of toxicity of AZD2171 and modified FOLFOX6. II. To determine the progression-free survival of subjects with advanced biliary cancers treated with AZD2171 and modified FOLFOX6.

Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral CT scan

No patients with proteinuria not meeting the criteria below; urine sample must be tested by urine protein:creatinine (UPC) ratio or by urinalysis method within 1 week of starting study treatment; depending upon the testing method used, the following criteria must be met:

UPC ratio must be < 1.0; if UPC ratio is ≥ 1.0, a 24-hour urine specimen must be collected and must demonstrate < 1 g of protein

Urinalysis must indicate 0-1+ protein; if urinalysis reading is ≥ 2+, a 24-hour urine specimen must be collected and must demonstrate < 1 g of protein

Not pregnant or nursing

Negative pregnancy test

Fertile patients must use adequate contraception (hormonal or barrier method of birth control; abstinence) before and during study treatment

Psychiatric illness/social situations that would limit compliance with study requirements

No patients with history of transient ischemic attack (TIA) or cerebrovascular accident (CVA) within 180 days prior to study treatment, symptomatic peripheral ischemia; history of arterial thrombotic event within 180 days prior to study treatment; gastrointestinal (GI) perforation within 180 days prior to study treatment

Patients who are chemotherapy naive unless chemotherapy was given as adjuvant post-surgical treatment and at least 6 months have elapsed since adjuvant chemotherapy

No patients who have had major surgical procedures, open biopsies, or significant traumatic injury within 28 days prior to study treatment

Chemotherapy for prior cancer is permitted

Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or PK of AZD2171 will be determined following review of their case by the Principal Investigator

Efforts should be made to switch patients with brain metastases who are taking enzyme-inducing anticonvulsant agents to other medications

Patients may not be receiving any other investigational agents nor have participated in an investigational trial within the past 30 days

Patients may not be receiving any medication that may markedly affect renal function (e.g., vancomycin, amphotericin, pentamidine)

Patients may not be receiving therapeutic doses of Coumadin or equivalent

No patients requiring drugs with proarrhythmic potential

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01229111